Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)

September 1, 2013 updated by: Shanghai University of Traditional Chinese Medicine
This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 210038
        • Recruiting
        • Shanghai University of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • He Qing, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women with normal menstrual cycles aged 40-50

Description

Inclusion Criteria:

  1. Healthy women with normal menstrual cycles aged 40-50.
  2. The score of Kupperman index is less than 15.
  3. Not alcoholics or smokers (past or smoking).
  4. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

  1. Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems.
  2. Volunteers are participating in other clinical trials within 3 months.
  3. Volunteers who donated blood or loosed blood heavily within 3 months.
  4. Volunteers with previous history of mental illness, drug abuse or drug dependence.
  5. Volunteers who took drugs within 14 days before the trail.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No drug intervention
The objective of this study is to investigate the expression of NEI network and urine metabolomics of healthy women with normal menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The expression of NEI network and Urine metabolomics
Time Frame: 2-5 days after menstruation

The indices of NEI network include:

  1. Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT
  2. Hypothalamic-pituitary-thyroid axis: TRH, T3, T4
  3. Renin - angiotensin - aldosterone system: PRA, Ang2, ALD
  4. Sex hormones: E2, FSH
  5. Immune factors: TNF-α、IL-6、IL-1
  6. Cardiovascular indicators: ET, NO, Hcy, Folic acid
2-5 days after menstruation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Wuxi People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 1, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QE-2458-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe